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Study of Bexxar <Tositumomab> Combined With External Beam Radiation Therapy

This study has been terminated.
(Low Accrual)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Susan Knox, Stanford University
ClinicalTrials.gov Identifier:
NCT00490490
First received: June 20, 2007
Last updated: February 9, 2017
Last verified: February 2017
Results First Received: December 19, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lymphoma, Non-Hodgkin
Interventions: Drug: Bexxar (tositumomab)
Procedure: External beam radiotherapy (XRT)
Drug: Potassium Iodide (KI)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Tositumomab + XRT + KI Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Participant Flow for 2 periods

Period 1:   Completed Assessment for CR
    Tositumomab + XRT + KI
STARTED   8 
COMPLETED   8 
NOT COMPLETED   0 

Period 2:   Completed Assessment for TTP
    Tositumomab + XRT + KI
STARTED   8 
COMPLETED   5 
NOT COMPLETED   3 
Withdrawal by Subject                1 
Lost to Follow-up                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Tositumomab + XRT + KI Tositumomab + external beam radiotherapy (XRT) + potassium iodide (KI)

Baseline Measures
   Tositumomab + XRT + KI 
Overall Participants Analyzed 
[Units: Participants]
 8 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      5  62.5% 
>=65 years      3  37.5% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  25.0% 
Male      6  75.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      7  87.5% 
Unknown or Not Reported      1  12.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      7  87.5% 
More than one race      0   0.0% 
Unknown or Not Reported      1  12.5% 
Histology [1] 
[Units: Participants]
Count of Participants
 
Follicular Lymphoma, Grade 1      2  25.0% 
Follicular Lymphoma, Grade 2      2  25.0% 
Follicular Lymphoma, Grade 3      2  25.0% 
Marginal Zone B-Cell Lymphoma      2  25.0% 
[1]

Participants were staged according to the Ann Arbor Staging Classification System, as below.

Stage / Characteristics

  1. Involvement of 1 lymphatic region
  2. Involvement of 2+ lymphatic regions on the same side of the diaphragm
  3. Involvement of lymphatic regions on both sides of the diaphragm
  4. Diffuse or disseminated involvement of 1+ extralymphatic organs


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Response (CR) Rate   [ Time Frame: 12 weeks ]

2.  Secondary:   Overall Response Rate (ORR)   [ Time Frame: 12 weeks ]

3.  Secondary:   Time-to-Progression (TTP)   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Susan J. Knox, MD, Associate Professor of Radiation Oncology
Organization: Stanford University Medical Center
phone: (650) 725-2720
e-mail: sknox@stanford.edu



Responsible Party: Susan Knox, Stanford University
ClinicalTrials.gov Identifier: NCT00490490     History of Changes
Other Study ID Numbers: IRB-07479
97437 ( Other Identifier: Stanford University Alternate IRB Approval Number )
LYMNHL0046 ( Other Identifier: OnCore )
Study First Received: June 20, 2007
Results First Received: December 19, 2016
Last Updated: February 9, 2017